OncoMatch/Clinical Trials/NCT03166397
Adoptive Cell Therapy Following a Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients
Is NCT03166397 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for malignant melanoma stage iv.
Treatment: Fludarabine · Cyclophosphamide · TIL · IL-2 · Nivolumab · Ipilimumab · FMT Protocol — Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with lymphodepletion and high-dose interleukin 2 (IL-2) has demonstrated reproducible objective response rates of approximately 50 percent in patients with highly advanced, refractory metastatic melanoma. Recent developments in theTIL ACT procedure facilitate the use of a reduced-intensity, non-myeloablative, lympho-depleting preparative regimen which is expected to be both less toxic and equally efficient compared to previous regimens. Recently patients recruited post Anti PD-1 therapy had inferior responses in comparison to the pre immune checkpoint inhibitors era. Therefore 2 new arms were added: 1. TIL-ACT with combination of 2 doses of Nivolumab fixed dose 480mg, pre and post TIL. 2. TIL-ACT with FMT given using colonoscopy once and 2 maintenance doses of 12 orally ingested capsules, concurrently with a single dose of Ipilimumab 1 mg/kg up to 100 mg.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage IV
Metastatic disease required
Measurable metastatic Melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
ANC >1000/mm3 without filgrastim; WBC >3000/mm3; Hgb >8.0 g/dL; platelets >100,000/mm3
Kidney function
Serum creatinine ≤1.6 mg/dL
Liver function
Serum ALT/AST <3x ULN; total bilirubin ≤1.5x ULN (except Gilbert Syndrome: <3 mg/dL)
Cardiac function
LVEF >50%; no history of coronary revascularization or ischemic symptoms; no clinically significant arrhythmias
Hematology: Absolute neutrophil count greater than 1000/mm3 without support of filgrastim Normal WBC (greater than 3000/mm3). Hemoglobin greater than 8.0 g/dL Platelet count greater than 100,000/mm3 Serology: Seronegative for HIV antibody. Seronegative for Hepatitis B or Hepatitis C. Chemistry: Serum ALT/AST less than three times the upper limit of normal (ULN). Serum creatinine less than or equal to 1.6 mg/dL Total bilirubin no more than 1.5 times the ULN, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3 mg/dL. Any patient known to have an LVEF less than or equal to 50 percent [excluded]. Documented LVEF of less than or equal to 50 percent tested in patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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